University of Cincinnati. Quality Assurance. and. Radiation Protection Manual. for. Non-Human Use. Radiation Generating. Equipment

Transcription

1 University of Cincinnati Quality Assurance and Radiation Protection Manual for Non-Human Use Radiation Generating Equipment

2 RECORD OF REVISION PAGE Revision # Date of Revision Change Entered Original 9/15/ /18/2004 Incorporated new or revised ODH regulations; added an audit function for the Radiation Safety Office. 2 2/15/2006 Added statement University of Cincinnati issued dosimeters cannot be used outside the RCSP. Statement added to section 9.6. Added this record of revision page. Updated Notice to Employees sample. 3 6/17/06 Incorporated updated forms and ODH notice to employees. The documents are attachments to the manual and were approved by the RSC for The University Hospital leaving the RCSP. 4 1/1/08 Corrected typographical error in Appendix B. Corrected collar multiplication factor in footnote from 0.4 to /20/08 Modified Appendix B, ALARA Investigational Levels, to delete special investigational level for the head. 6 5/13/09 Modified manual to incorporate new QA requirements enacted by the ODH in December Added reference to QA materials being available on the Radiation Safety website ( Corrected minor typographical errors and style inconsistencies. 7 2/16/11 Added IRRP to list of abbreviations, updated RGE type definitions to be equivalent to current ODH definitions, added requirements for use of new RSC approved form for inoperable RGE; corrected a few typographical errors noted. 8 5/16/12 Corrected an error in the examples under industrial irradiation device ; a bomb detection unit is an industrial radiography not an irradiation device. Updated requirements for regulatory changes effective 5/1/12, including incorporation of new OAC 3701:1-68 rules. Replaced biannually with biennially to make it clear that RSC audits are every other year. Removed all references to particle accelerator and veterinary mammography, since there are none under the RCSP. Corrected some typographical and formatting errors.

3 TABLE OF CONTENTS 1 General 1 2 Purpose 2 3 Definitions and Abbreviations Definitions Abbreviations 3 4 QA Program 4 5 Audits 4 6 RGE Operator Requirements 5 7 Training Requirements Radiation Worker (e.g., operators) Ancillary Worker Documentation 9 8 Radiation Safety Procedures All Non-Human Use RGE Additional Safety Procedures by RGE Type Industrial radiography and irradiation RGE enclosed in a cabinet Industrial radiography RGE used for bomb detection Industrial radiography and irradiation RGE that are neither in a cabinet 10 or used for bomb detection Industrial analytical RGE enclosed in a cabinet Industrial analytical open beam RGE Veterinary RGE radiographic and CT units Veterinary RGE fluoroscopy, including C-arm Additional Requirements for Specific Workers Pregnant worker Minor 14 9 Radiation Monitoring Requirements Exposure Limits General Personnel Dosimetry Requirements Specific Personnel Dosimetry Requirements by RGE Type Industrial radiography RGE Industrial irradiation device Industrial analytical RGE Veterinary use RGE Specific Personnel Dosimetry for Specific Types of Worker Dosimetry for ancillary workers Dosimetry for declared pregnant worker Area Dosimeter Option Care of Dosimetry Dosimetry Analysis and Reports Dosimetry Exchange Procedures Lost, Late Return or Damaged Dosimeters 17 I

4 TABLE OF CONTENTS 10 ALARA and Overexposure Investigations and Notifications ALARA Investigation and Notification Overexposure Investigation and Notification Postings and Signs Incident Action Intervals and Procedures for Evaluation of RGE Quality Control (QC) Tests RGE Logs and Operation Manuals Logs Maintenance Log Use Log Operation Manual RGE Acquisition, Inventory, and Disposal or Transfer Acquisition Inventory Disposal or Transfer Inoperable Units RGE Room Construction New or Remodeled 25 Appendix A - Forms Appendix B - ALARA Investigational Levels Appendix C - Sample Posting II

5 General 1.1. The possession and/or use of radiation generating equipment (RGE) classified by the state of Ohio as industrial radiography equipment, industrial irradiation device, industrial analytical and/or veterinary use (i.e., on animals) RGE shall be conducted in accordance with policies, procedures and guidelines presented in this manual "Industrial radiography equipment" means any RGE which produces ionizing radiation to examine the macroscopic structures of material by nondestructive testing methods. Industrial radiography units include RGE used for bomb detection Industrial irradiation device means any RGE used to alter the chemical, biological or physical properties of materials or to sterilize materials. Industrial irradiation devices include, but are not limited to, electron beam processors, electron beam welders, electron beam coaters, and cabinet irradiators "Industrial analytical" RGE means a group or system of components which produce ionizing radiation as either a primary or secondary result and is used to determine or alter properties of materials being measured or analyzed. Industrial analytical RGE include, but are not limited to, gauging units, x-ray diffraction devices, x-ray spectrometer devices, and electron microscopes Veterinary RGE includes any radiographic or fluoroscopic unit used for the diagnostic imaging or real-time imaging of animals or to administer a radiation dose to an animal Each department possessing RGE and each contact person (CP) responsible for one or more industrial radiography equipment, industrial irradiation device, industrial analytical, and/or veterinary RGE under the University of Cincinnati Radiation Control and Safety Program (RCSP) shall maintain a copy of this manual The CP is responsible for ensuring a copy of this manual is readily available to personnel for consultation and information purposes The chair of each department possessing RGE is responsible for ensuring a CP is designated for each RGE possessed by the department and the designated CP is an individual currently employed by the institution with sufficient knowledge, time and authority to perform the duties of the CP This manual incorporates quality assurance (QA) and radiation protection policies, procedures and guidelines, as applicable to non-human use RGE The Radiation Safety Committee (RSC) has reviewed and approved the initial and each subsequent version of this manual The Individual Responsible for Radiation Protection (IRRP)/Radiation Safety Officer (RSO) is responsible for ensuring the current version of the manual is posted on the Radiation Safety website ( The manual shall be updated as necessary to reflect changes in policies, procedures, institutional equipment and/or regulatory changes The IRRP/RSO is responsible for distributing copies of each revision to Page 1 of 25

6 each CP within 30 days of RSC approval The CP is responsible for ensuring each RGE radiation worker (RW) under their responsibility is informed regarding applicable changes incorporated in a revision within 60 days of RSC approval All employees operating RGE for non-human use shall read and understand this manual prior to operating RGE. 2. Purpose 2.1. The purpose of this manual is to satisfy the requirements of the Ohio Administrative Code (OAC) regarding the provisions of for quality assurance (QA) and radiation protection QA requirements for veterinary RGE are listed in OAC 3701: QA requirements for industrial RGE are listed in OAC 3701: General radiation protection requirements are listed in OAC 3701: Machine specific requirements for veterinary RGE are listed in the applicable OAC 3701:1-66 rule for the specific RGE type Machine specific radiation safety requirements are industrial RGE are listed in the applicable OAC 3701:1-66 rule for the specific RGE type This manual also provides significant regulatory requirements that may impact day-today usage of non-human use RGE. 3. Definitions and Abbreviations 3.1. Definitions Ancillary Radiation Worker (AW) An individual who is not a RW is in the restricted area (e.g., room) when the RGE is energized (e.g., x-ray is on) (and) is performing a duty as part of their "job" (e.g., employee, student, volunteer) Cabinet x-ray system A RGE with the x-ray tube installed in a shielded enclosure such that every location on the exterior of the cabinet meets the dose limits for a member of the public. The cabinet must contain a least a portion of the material being irradiated and must be designed to and small enough to exclude a person from its interior during generation of radiation Contact Person (CP) An individual designated by a department, division or unit as responsible for ensuring compliance with policies, procedures and guidelines covered Page 2 of 25

7 in this manual Declared pregnant worker An RW or AW who has declared their pregnancy in writing to the Radiation Safety Office (RSOf) Direct supervision Within eye sight of the individual providing the supervision Enclosed x-ray system Industrial RGE operated in an enclosure or cabinet Minor Any individual under the age of RGE Radiation Worker (RW) An individual who operates a RGE Restricted area For industrial radiography RGE, the restricted area is that area where the dose rate may exceed 2 millirem in any one hour For industrial irradiation device, the restricted area is the RGE unit and associated shielding and/or housing, or any area where the dose rate may exceed 2 millirem in any one hour, whichever is larger For industrial analytical RGE, the restricted area is the RGE unit and associated shielding and/or housing, or any area where the dose rate may exceed 2 millirem in any one hour, whichever is larger For veterinary RGE, the restricted area is the room in which the RGE is present when energized or 6 feet from the x-ray tube, whichever is smaller Abbreviations AW: Ancillary Radiation Worker CP: Contact Person IRRP Individual Responsible for Radiation Protection ODH: Ohio Department of Health QA: Quality Assurance RCSP: Radiation Control and Safety Program RGE: Radiation Generating Equipment RSC: Radiation Safety Committee RSO: Radiation Safety Officer RSOf: Radiation Safety Office Page 3 of 25

8 RW: RGE Radiation Worker 4. QA Program 4.1. The QA Program addresses the following: Intervals and procedures for evaluation of RGE (manual section 13) Radiation monitoring including audits and surveys (manual sections 5 and 13), occupational exposure limits (manual section 9.1), maintenance of records (manual section 9.7) and procedure regarding the use of personnel and/or area monitoring (manual sections ) ALARA and overexposure notification (manual section 10) Radiation safety specifics for each type of RGE (manual section 8) RGE operator training (manual sections 6 and 7) General training (manual section 7) Quality control tests and frequencies (manual section 14) Notification of QA Program changes (manual paragraphs 1.3 and 7.1.4) RGE RW roles and responsibilities (RCSP Manual, manual paragraphs 1.2, 3.1.1, 3.1.2, and 13.4) Personnel protection (manual paragraph 6.3) Prenatal exposure (manual paragraph 8.3.1) AW training (manual section 7.2) QC task responsibilities and training (none specified in rule for industrial RGE) Protection of the public (manual sections 6.4 and 11) Equipment logs (manual section 15) Posting and signage (manual section 11) Incident action (manual section 12) 4.2. Oversight and Maintenance of the QA Program Oversight and maintenance of the QA Program for non-human use RGE is the responsibility of the RSC Implementation of the QA Program Implementation of the QA Program for non-human RGE is the responsibility of the University of Cincinnati IRRP/RSO. 5. Audits 5.1. Each RGE shall be audited by the Radiation Safety Office (RSOf) as deemed necessary by the IRRP/RSO to ensure compliance with rules, regulations and/or good health physics practices The minimum frequency of RSOf audits shall be annual. Page 4 of 25

9 The audits, at a minimum, shall include a review of significant regulatory and program requirements The CP shall ensure an operator is available to operate the RGE, as necessary, during RSOf audits The QA Program, as it applies to non-human use RGE, shall be audited at least biennially as part of the annual RCSP audit performed by the RSC RSC audits shall include, at least one of the following: a review of RGE audits and/or surveys performed by the RSOf a review of RGE inspections performed by the ODH and the status of the implementation of corrective action a review of QA policies and procedures 6. RGE Operator Requirements 6.1. Before operating any RGE, the operator shall ensure they are familiar with the RGE's operating characteristics, as well as the purpose and function of protective devices. Any operator who has questions concerning or doubts regarding the operation of a RGE shall immediately seek guidance from their supervisor or other appropriate individual Operators shall report promptly to their CP any condition they believe might lead to or cause a violation of rules or regulations, or unnecessary exposure to radiation. If the condition goes uncorrected, the operator shall report the condition to the IRRP/RSO Operators shall minimize their and other individual s in the restricted area radiation exposure by: Reducing the time in the restricted area Staying as far away as possible from the radiation beam (e.g., increasing distance) Wearing any required protective shielding (e.g., lead apron) Ensuring protective devices, such as interlocks and protective housing or shielding, are functioning as designed for the specific RGE Operators shall minimize radiation exposure to members of the public by: Closely following RGE operating procedures Not overriding interlocks or other safety features Ensuring members of the public are not in the restricted area whenever an RGE is energized Operators who are minors shall: Obtain written approval from their parents or guardians. Both the Release of Liability and Waiver Claim for Minors form (RS Form 38) and the Supervisor s Statement for Minors form (RS Form 38A) shall be completed. Both forms are available on the Radiation Safety website ( Page 5 of 25

10 Be limited to an occupational dose of 0.5 rem total effective dose equivalent per year. 7. Training Requirements 7.1. Radiation Worker (RW), e.g., operators Prior to allowing an individual to operate a non-human use RGE, the CP shall ensure the individual has obtained sufficient training to operate the RGE competently and safely. At a minimum, this training must include: general radiation safety training the general radiation safety training for RW shall include: possible health effects from exposure to radiation general precautions and procedures to minimize exposure to radiation instruction to watch for and report promptly any condition that may constitute or lead to or cause a violation of radiation protection or QA procedures, policies, rules or regulations (and) applicable warning signage the general radiation safety training for RW may be obtained by: viewing the general radiation protection training film available to be viewed at or signed out from the RSOf, or available to be viewed on the Radiation Safety website ( attending the RSOf Basic training course (course session schedule available from the RSOf or on the Radiation Safety website (or) the CP (or designee) providing equivalent instruction area specific training - the CP (or designee) shall provide instruction that includes: a review of the QA manual the location and purpose of the restricted area a description and location of RGE(s) in use (and) appropriate response to warnings or unusual conditions machine specific training - the CP or an approved machine operator designated by the CP shall provide instruction that includes: machine operating instructions unit specific safe operating procedures location of and documentation requirements for maintenance and use logs (and) Page 6 of 25

11 additional training applicable to the RGE to be operated/used industrial radiography and irradiation RGE bomb detection units record-keeping requirements survey requirements restricted area control requirements, such as ropes, tapes and signs cabinet radiography or irradiation RGE all other industrial radiographic RGE meet the training requirements listed in OAC 3701: (E) industrial irradiation device how to use a survey meter and perform a pre-operational check to check for obvious defects prior to each day the RGE is used to check control devices and/or alarm systems for high radiation areas at the beginning of each day the RGE is used industrial analytical RGE x-ray diffraction and spectroscopy units view one of the films covering radiation safety for analytical units, which can be viewed at or signed out from the RSOf and include: The Double Edged Sword X-ray Diffraction Hazards, Howard Hughes Institute review machine alignment techniques discuss interlocks and safety controls and the importance of using them as intended (e.g., not overriding interlocks) all veterinary use RGE procedures for holding and/or stabilizing the animal where to stand during a procedure veterinary fluoroscopy units, including C-arms review the fluoroscopy training manual Page 7 of 25

12 pass the fluoroscopy test Annually, a competency assessment shall be performed which shall include: an assessment by the CP (or designee) of the individual s ability to competently and safely operate each pertinent RGE; this assessment may be performed: by the individual reviewing their skills with the supervisor (or) the supervisor observing the individual operating the RGE New equipment - when new RGE is installed operators shall be trained in the operation by: the manufacturer an operator or supervisor who was trained by the manufacturer (or) an operator or supervisor who is skilled at using the RGE (e.g., individual trained by an individual who was trained by the manufacturer) Changes to operating procedures and/or the QA Program shall be communicated to applicable operators in a timely manner, but no later than 60 days after the change by: written and/or verbal communication (e.g., memo to operators, discussion at departmental meeting) from the CP (or designee) (and) addition of revised procedure in the RGE operations manual 7.2. Ancillary Worker (AW) All AWs who may receive an occupational dose under the RCSP in excess of 100 millirem (0.1 rem) shall receive: general radiation protection training the general radiation safety training for AW shall include: possible health effects from exposure to radiation general precautions and procedures to minimize the exposure instruction to watch for and report promptly any condition that may constitute or lead to or cause a violation of radiation protection or QA procedures, policies, rules or regulations (and) applicable warning signage the general radiation safety training for AW may be obtained by: viewing the general radiation protection training film available to be viewed at or signed out from the Radiation Safety Office, or available to be viewed on the Radiation Safety website ( attending the RSOf Basic training course (course session schedule available through the RSOf or on the RSOf website Page 8 of 25

13 (or) the CP (or designee) providing equivalent instruction area specific training - the CP (or designee) shall provide instruction that includes: 7.3. Documentation the location and purpose of the restricted area (and) a description and location of the RGE in use All training shall be documented and the documentation shall be maintained by the CP. If the individual will be monitored (i.e., issued a dosimeter), copies of the documentation shall be forwarded to the RSOf, along with the dosimeter application. The dosimeter application form Radiation Worker/Dosimeter Application (RS Form 2.0) is available on the Radiation Safety website ( The form Radiation Safety Training for Non-Human Use RGE (RS form 2.1(x-ray non-human)), or its equivalent, shall be used to document the training. A copy of RS form 2.1(x-ray non-human) is included in appendix E of this manual and is available on the Radiation Safety website ( 8. Radiation Safety Procedures 8.1. All Non-Human Use RGE All individuals shall wear their assigned dosimeters as required (see radiation monitoring requirements, section 9) All individuals must operate the RGE in accordance with manufacturer s operating procedures or procedures approved in writing by the IRRP/RSO All individuals must abide by the machine operating instructions and the unit specific safe operating procedures All RGE must be secured from tampering and unauthorized use Additional Safety Procedures by RGE type: Industrial radiography and irradiation RGE enclosed in a cabinet: a readily visible failsafe warning light must be present on or near the source housing labeled with the words x-ray on that notifies individuals the x-ray is on a readily discernible sign must be present bearing the radiation symbol and the words: Caution High Intensity X-ray Beam or equivalent on or near the source housing, and Caution This Equipment Produces Radiation When Energized or equivalent near any switch or control that directly Page 9 of 25

14 energizes the unit Industrial radiography RGE used for bomb detection: a readily visible failsafe warning light must be present on or near the source housing labeled with the words x-ray on or equivalent that notifies individuals the x-ray is on a readily discernible sign must be present bearing the radiation symbol and the following or equivalent wording: Caution High Intensity X-ray Beam on or near the source housing, and Caution This Equipment Produces Radiation When Energized any switch or control that directly energizes the unit an operable calibrated survey instrument must be available at each use site where the bomb detection unit may be used appropriate barriers must be used to keep out unauthorized individuals and ensure exposure to radiation from the RGE does not exceed regulatory limits when not in use, the RGE must be secured within a locked area Industrial radiographic or irradiation RGE that are neither in a cabinet or used for bomb detection: a readily visible failsafe warning light must be present on or near the source housing labeled with the words x-ray on or equivalent that notifies individuals the x-ray is on a readily discernible sign must be present bearing the radiation symbol and the following or equivalent wording: Caution High Intensity X-ray Beam on or near the source housing, and Caution This Equipment Produces Radiation When Energized any switch or control that directly energizes the unit whenever the RGE is energized, two individuals must physically be present at the job site and at least one of the individuals must be an approved operator an approved operator must be physically present to ensure security of high radiation areas or any high radiation area must be protected by interlocked failsafe safety mechanisms an operable calibrated survey instrument must be available at each use site each operator or individual within the restricted area must wear an appropriate direct reading personnel dosimeter, along with dosimetry described in 9.3 of this manual Page 10 of 25

15 appropriate barriers and signage must be used to warn individuals, keep out unauthorized individuals and ensure exposure to radiation from the RGE does not exceed regulatory limits a survey must be performed after each use to ensure the beam is off when not in use, the RGE must be secured within a locked area Industrial analytical RGE enclosed in a cabinet: the cabinet must be interlocked to ensure the beam is shut off if the cabinet is breached the cabinet must ensure dose rates outside the cabinet are less than 0.25 millirem per hour at 5 centimeters any temporary alteration of safety devices, including by-passing interlocks or removing shields must be approved in writing in advance by the IRRP/RSO; this approval shall be: documented and documentation must include the date of alteration and the length of time the alteration will be in effect, along with IRRP/RSO s signature posted near the RGE source housing when applied (and) maintained with RGE records for at least 3 years radiation leakage surveys must be performed after non-routine operations, such as maintenance, repair or alignment; the surveys shall be: performed by the CP (or) upon request, the RSOf documented and documentation maintained with RGE records for at least 3 years Industrial analytical open beam RGE: a interlocked failsafe device must be present to prevent entry of any portion of an individual s body into the primary beam all unused ports must be secured in the closed position a readily visible failsafe warning light must be present on or near the source housing that notifies individuals the x-ray is on any temporary alteration of safety devices must be approved in advance by the IRRP/RSO; this approval shall be: documented and documentation must include the date of alteration and the length of time the alteration will be in effect, along with the IRRP/RSO s signature posted near the RGE source housing when applied (and) Page 11 of 25

16 maintained with RGE records for at least 3 years radiation leakage surveys shall be performed after non-routine operations, such as maintenance, repair and alignment; the surveys shall be: performed by the CP (or) upon request, the RSOf documented and documentation maintained with RGE records for at least 3 years Veterinary RGE radiographic and CT units: individuals whose presence during an exam is not required shall not stay as an observer unless required as a part of the clinical learning process reasonable efforts shall be made to avoid holding animals during radiologic examinations; immobilization devices and restraint devices shall be used whenever possible to avoid holding the animal being x-rayed individuals in the restricted area shall minimize their radiation exposure by: minimizing the time spent in the restricted area when the RGE is on staying as far away as possible from the radiation beam (e.g., increasing distance) wearing appropriate protective shielding aprons of at least 0.5 mm lead equivalence in front shall be worn by all individuals in the restricted area gloves of at least 0.25 mm lead equivalence shall be worn by all individuals whose hands are in or close to the "primary beam" because of the need to hold an animal collar shields (i.e., thyroid shields) of at least 0.5 mm lead equivalence shall be worn by individuals who risk significant exposure to the head and neck (e.g., within a few feet of an energized fluoroscopic unit or C-arm) the holding of film cassettes shall be minimized; if a film cassette must be held then lead-lined gloves shall be worn Veterinary RGE - fluoroscopic, including C-arms individuals who must be in the restricted area during a procedure shall stand as far away from the tube as practical individuals who must work in the restricted area when the RGE is activated shall wear protective apparel, under no circumstances shall less than a lead apron, 0.5 mm lead equivalent, be worn Page 12 of 25

17 lead gloves shall be worn when the hands must be placed in the primary x-ray beam lead thyroid shields, lead eyeglasses and protective barriers should be used as applicable portable protective shields shall be used when possible for permanent installations, a table apron shall be installed and used unless it interferes with the procedure or compromises a sterile field avoid unnecessary fluoroscopic exposure use image freeze capabilities when possible utilize pulsed fluoroscopy techniques if the machine is so equipped conduct examinations with as little fluoroscopy time as possible 8.3. Additional Requirements for Specific Workers Pregnant worker: pregnant workers may choose to declare their pregnancy, at which time lower doses will apply pregnant workers are not considered declared pregnant workers until they declare the pregnancy in writing to the RSOf the declaration must include the following information (The RSC approved form Declaration of Pregnancy (RS Form 33) is available on the Radiation Safety website ( and may be used to declare a pregnancy.) the name of the individual the date of declaration the type of radiation exposed to in the workplace (and) the estimated date of conception the radiation dose limit to the fetus/embryo of a declared pregnant worker is 500 millirem total effective dose equivalent over the term of the pregnancy declared pregnant workers may request a meeting with the IRRP/RSO and during this meeting the IRRP/RSO will: review the individual's exposure record if the record indicates an exposure to the embryo/fetus greater than 500 millirem may occur, the IRRP/RSO will initiate steps to move the individual to a position of lower radiation exposure and one that the exposure can be maintained less than 500 millirem review procedures to minimize exposure to the embryo/fetus (and) Page 13 of 25

18 answer any questions the individual may have pregnant individuals may continue to operate and work around RGE unless deemed otherwise by the IRRP/RSO pregnant individuals shall not enter or be in a restricted area unless they are wearing a lead protective apron pregnant individuals should consider wearing the wrap-around type apron whenever possible as they provide the best protection pregnant individuals should review NRC regulatory guide 8.13; this guide Minor covers the effects of radiation to the embryo and fetus is available on the NRC website ( or from the RSOf minors shall have written authorization from their parent(s) or guardian(s) authorizing their potential exposure to radiation (The Release of Liability and Waiver Claim for Minors form (RS Form 38) and the Supervisor s Statement for Minors (RS Form 38A) form shall be completed. Both forms are available on the Radiation Safety website ( minors, who are RWs or AWs, are limited to a radiation dose that is 10% of the limits for other workers 9. Radiation Monitoring Requirements 9.1. Exposure Limits The annual occupational exposure limits are: Adult Whole body effective dose - 5 rem Any individual organ or tissue, other than the lens of the eye - 50 rem Lens of the eye - 15 rem Skin - 50 rem Extremity - 50 rem Minor one tenth adult value Declared pregnant worker 0.5 rem (500 millirem) to the fetus during the pregnancy 9.2. General Personnel Dosimetry Requirements In accordance with regulations at a minimum dosimetry shall be worn by all personnel who may receive greater than 10% of the annual limit. However, under the RCSP additional (more restrictive) dosimetry is required as outlined in this manual, or as deemed necessary by the RSC Dosimetry used for individuals exposed to RGE shall be able to detect photon radiation. Page 14 of 25

19 Dosimetry shall be provided by and applied for through the RSOf Specific Personnel Dosimetry Requirements by RGE Type Industrial radiography RGE one dosimeter at waist or collar, whichever location would result in the highest exposure Industrial irradiation device one dosimeter at waist or collar, whichever location would result in the highest exposure Industrial analytical RGE electron microscopes no dosimetry required diffraction and spectrometry RGE one dosimeter at waist or collar, whichever location would result in the highest exposure Veterinary use RGE whole body dosimetry radiographic and CT units one dosimeter at the collar, outside any lead apron worn fluoroscopy units, including C-arms two dosimeters, as labeled one dosimeter outside the apron, at the collar (labeled neck or collar) second dosimeter under the apron, at waist level (labeled waist or chest) hand dosimetry if an individual s hands are frequently (e.g., weekly) in the x-ray beam, hand dosimetry is also required a ring dosimeter shall be worn on each hand frequently in the x-ray beam 9.4. Specific Personnel Dosimetry for Specific Types of Workers Dosimetry for ancillary workers (AW) dosimetry is required if the AW is frequently (i.e., weekly or 10 hours/month with x-ray on) in the restricted area dosimetry requirements for frequently exposed AW are equivalent to that for RW Page 15 of 25

20 Dosimetry for declared pregnant workers declared pregnant workers who frequent the restricted area shall be assigned a dosimeter to be worn at the waist if lead apron is worn one dosimeter worn outside the apron, at the collar (labeled neck or collar) second dosimeter worn under the apron, at waist level (labeled waist or chest) if lead apron is not worn 9.5. Area Dosimeter Option one dosimeter worn at waist level A CP may request an area dosimeter for placement in a location of interest to monitor radiation exposure at the location. Locations of interest may include, the control panel or locations where members of the public may frequent Care of Dosimetry Assigned personnel dosimetry must be worn whenever there is a potential for occupational radiation exposure Personnel and area dosimeters issued by the University of Cincinnati are limited for use to monitor radiation exposure from radiation sources covered by the RCSP Personnel dosimeters are for use by a single individual and shall not be shared, reassigned or discarded. Area dosimeters are for use at a single designated location Personnel dosimetry does not provide protection from radiation; it only provides an "after the fact" assessment of radiation to which it (and presumably the wearer) was exposed Dosimeters shall be worn at the position appropriate for the work being performed (see personnel monitoring, section 9.3) Radiation dosimeters are very sensitive to environmental conditions such as heat, light and moisture. Dosimeters should be used properly, should not be taken home or stored in cars or on window sills Radiation dosimeters shall be stored in low background areas (e.g., offices, non- RGE area) when not being worn or used to monitor a specific location Personnel radiation dosimeters are for occupational exposure only and are NOT to be worn during personal medical or dental procedures Radiation dosimeters are to be exchanged in a timely manner (see section 9.8) If a dosimeter is lost, damaged or left in an area of high radiation exposure the RSOf must be notified immediately (see section 9.8). Page 16 of 25

21 9.7. Dosimetry Analysis and Reports Personnel dosimetry must be returned in a timely fashion to the RSOf for analysis per section 9.8 of this manual Dosimetry analysis reports are sent by the vendor to the RSOf. Copies are maintained in the RSOf. Copies are forwarded as follows: monthly series analysis reports: are forwarded to CPs who request, in writing, copies of the monthly report individual analysis reports: monitored personnel are issued copies of the previous year's exposure as an individualized report during the second quarter of the year (generally with the April or May dosimeters) monitored personnel are issued copies of individual dosimetry reports upon request requests must be made to the RSOf reports will be provided within 30 days after the request is made or within 30 days after receipt of the data for the last dosimeter, whichever is later 9.8. Dosimeter Exchange Procedures To prevent unmonitored exposure, before used dosimeters are returned, new dosimeters are picked up all dosimeters shall be picked up in the RSOf during the first 3 working days of the month all dosimeters shall be returned to the RSOf during the first 10 days of the month all late returned and non-returned dosimeters require completion of a radiation dosimetry follow-up form the RSOf shall issue the form upon receipt of a report indicating a dosimeter was not returned as required 9.9. Lost, Late Return or Damaged Dosimeters Lost or damaged dosimeters shall be reported immediately to the RSOf Temporary replacement dosimetry will be issued if dosimeters are lost or damaged prior to the return exchange A radiation dosimetry follow-up form is required to be completed for all lost, late return and damaged dosimeters the RSOf shall issue the form upon receipt of a report indicating a dosimeter was not returned or was damaged Page 17 of 25

22 10. ALARA and Overexposure Investigations and Notifications ALARA Investigations and Notification The basic rule for ALARA investigations is ALARA investigations shall be performed when individuals exceed 10% and 30% of the applicable regulatory limits for occupationally exposed individuals. However, to ensure timely ALARA review and implementation of corrective action, reviews are performed on a quarterly fraction, which is the annual limit divided by 4. The 10% and 30% is applied to the quarterly fraction. The current ALARA investigational level doses are listed in appendix B ALARA I (greater than 10% but less than 30% of regulatory limit) the IRRP/RSO, or designee will: provide a written report of the exposure to the individual request the individual submit an explanation of radiation exposure during the time period in question review the exposure and the explanation, then investigate if deemed necessary report the results to the RSC at the next meeting ALARA II (greater than or equal to 30% of regulatory limit) the IRRP/RSO, or designee will: provide a written report of the exposure to the individual request the individual submit an explanation of radiation exposure during the time period in question investigate the cause(s) of the exposure implement corrective action as deemed necessary report the results to the RSC at the next meeting Overexposure Investigation and Notification When an exposure in excess of regulatory limits is suspected the IRRP/RSO shall be notified The IRRP/RSO, or designee shall: investigate the possible overexposure notify the Director of the ODH within 30 days; the notification shall: describe the extent of the exposure and include: an estimation of the individual's dose the levels of radiation involved the cause of the exposure Page 18 of 25

23 any corrective action taken or planned to assure against recurrence and on a separate page list: the individual s name social security number date of birth provide written notification to the individual. The written notification shall include: nature and extent of the exposure the following statement "This report is furnished to you under provisions of rule 3701: of the administrative code. You should preserve this report for future reference." 11. Postings and Signs Posting and signage is the primary mechanism used to inform and protect the public from radiation exposure from non-human use RGE All doors to the room where RGE is stored or housed shall be posted with a sign that contains the radiation trefoil and states caution - equipment in this room may produce radiation when energized or equivalent Each room where RGE is stored or housed shall post in conspicuous locations the following (a sample posting is included in appendix C) ODH notice to employees Location(s) where this manual, applicable audit(s) and applicable inspection report(s) are maintained Location(s) where applicable rules and regulations are maintained. (and) Method for contacting the IRRP/RSO Each non-human use RGE shall have a label near any switch that energies the RGE (e.g., the x-ray tube) that states "caution-this equipment produces radiation when energized" or equivalent Each industrial radiographic RGE shall have a label on or near the source housing that states caution high intensity x-ray beam Each open beam industrial analytical RGE shall have a label on or near the source housing that states caution high intensity x-ray beam. 12. Incident Action Any problems with the operation of RGE shall be reported immediately to the CP Any problems reported to the CP that are not corrected in a reasonable amount of time shall be reported to the IRRP/RSO. Page 19 of 25

24 12.2. Any problems with the operation of RGE that an individual suspects may result in an overexposure (i.e., exposure greater than regulatory limits) shall be reported immediately to the CP and IRRP/RSO The IRRP/RSO, in conjunction with the CP, shall investigate the problem and implement corrective action Any suspected or known overexposure shall be immediately reported to the IRRP/RSO The IRRP/RSO shall investigate the overexposure and submit required reports to the ODH in accordance with section 10.2 of this manual. 13. Intervals and Procedures for Evaluation of RGE All industrial analytical RGE must be surveyed by the CP or arrangements made for a survey by the RSOf Surveys must be performed: following any change in the initial system arrangement or type of local components following any maintenance requiring disassembly or removal of a local component during the performance of maintenance or alignment procedures requiring activation of the RGE any time a visual inspection of local components reveal an abnormal condition Surveys must be performed with an appropriate calibrated survey meter The survey results must be documented the documentation must be readily available for inspection by the RSC, IRRP/RSO or ODH the survey results must be maintained with RGE records for 3 years All operable non-human use RGE shall be surveyed by the RSOf upon installation and by the CP in accordance with the following schedule thereafter, unless the IRRP/RSO determines more frequent surveys are required industrial radiography: cabinet - annually bomb detection units annually all other non-cabinet quarterly industrial irradiation device - quarterly industrial analytical: electron microscopes annually Page 20 of 25

25 all others - semiannually veterinary RGE annually RSOf surveys, at a minimum, shall include a radiation survey of the RGE and a review of RGE safety features, as required by regulations The CP must ensure an operator is available to operate the RGE, as necessary, during RSOf surveys Each CP for veterinary fluoroscopy RGE shall arrange for a radiation expert (e.g. medical physicist) to evaluate the RGE to ensure compliance with machine specifications regulations These evaluations shall be performed prior to first use and annually thereafter These evaluations shall include: tests to determine compliance with spot film device limits evaluation of fluoroscopic image quality tests to determine entrance exposure rates The results of the evaluation shall be documented the documentation must be readily available for inspection by the RSC, IRRP/RSO or ODH the documentation must be maintained with RGE records for 3 years All non-human use RGE shall be evaluated by the ODH in accordance with the inspection schedule of the ODH The CP must ensure an operator is available to operate the RGE, as necessary, during ODH inspections In accordance with Ohio Revised Code, the ODH may inspect RGE without advanced notice. If advanced notice is provided to the IRRP/RSO, the IRRP/RSO will inform the affected CP(s) The CP is responsible for the cost associated with any fee assessed by the ODH for an inspection of their RGE. 14. Quality Control (QC) Tests No QC tests are required for non-human use RGE. 15. RGE Logs and Operation Manuals Logs - each RGE will have a separate maintenance log and use log Maintenance log - the maintenance log shall include: identification of the piece of equipment incidents and actions maintenance performed Page 21 of 25

26 repair information incident summaries Use log - the use log shall include: RGE identification date of operation operator s name brief description of use for fluoroscopic units, including C-arms the procedure s total air kerma or dose area product, or alternately the mode of operation (e.g., high or pulsed mode), the cumulative fluoroscopy time and/or the number of spot films if the fluoroscopy unit is being used for an animal, the animal s identification and type of examination performed (this may be included in the brief description of use) for industrial radiography RGE and industrial irradiation device the kvp the ma the on time for industrial radiography RGE and industrial irradiation device used at temporary locations date the RGE is removed from storage date the RGE is returned to storage result of any surveys performed Operation Manual - each RGE shall have an operation manual which includes, at a minimum: a list of operators a copy of this manual (and) machine operating procedures and unit specific safe operating procedures for industrial radiography RGE and industrial irradiation device the procedure(s) must also include: emergency procedures methods and occasions for conducting radiation surveys methods for controlling access to radiation areas methods for securing the RGE from unauthorized use Page 22 of 25

27 15.3. RGE maintenance logs, use logs and operation manuals shall be: maintained in the area (e.g., room) where the RGE is housed readily available for use by the operator(s) available for inspection by the RSC, IRRP/RSO or ODH 16. RGE Acquisition, Inventory, Disposal or Transfer, and Inoperable Units Acquisition The CP (or individual who will be the CP upon RGE receipt) is responsible for reporting the anticipated acquisition of RGE to the IRRP/RSO new purchases - reporting shall be within 30 days of order placement, and at least 30 days prior to the anticipated date of receipt of the RGE additional notification time is required for veterinary (radiographic, CT and fluoroscopic) RGE the notification must be sufficient for the IRRP/RSO to review, modify if necessary, and approve any facility design associated with the RGE purchase facility design reviews involve a minimum of 30 days (see section 17) replacements - reporting shall be within 30 days of order placement and at least 5 working days prior to the anticipated date of receipt of the new RGE loaners - reporting shall be as soon as possible, but within 5 working days prior to the anticipated date of receipt of the loaner RGE Information provided to the IRRP/RSO shall include, but is not limited to: CP's name department machine's application (e.g., veterinary radiographic, industrial radiographic, electron microscope) description of machine (make, model) number of tubes expected delivery date planned location The IRRP/RSO will ensure the state of Ohio registration allows for the acquisition. If the acquisition will result in the number of tubes exceeding the number listed on the registration, the IRRP/RSO shall amend the registration Upon install and prior to use, the CP shall arrange for and ensure: acceptance testing is performed by the manufacturer and/or installer Page 23 of 25